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Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323451
Recruitment Status : Unknown
Verified December 2014 by Shanghai Qisheng Biological Preparation Co., Ltd..
Recruitment status was:  Recruiting
First Posted : December 23, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Shanghai Qisheng Biological Preparation Co., Ltd.

Brief Summary:
This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Medical Chitosan Drug: Sodium Hyaluronate Injection Phase 4

Detailed Description:
Medical chitosan and sodium hyaluronate each form the reticular layer to cover the joint surface, alleviate the joint friction and pain. For medical chitosan, its half-life is longer than sodium hyaluronate, so the interval time of intra-articular injection is longer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-blinded, Parallel-controlled, Non-inferiority Clinical Study Of Safety and Efficacy Of Medical Chitosan for Knee Osteoarthritis Compared With Sodium Hyaluronate Injection
Study Start Date : December 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Medical Chitosan
Medical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times
Device: Medical Chitosan
intra-articular injection

Active Comparator: Sodium Hyaluronate Injection
Sodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times.
Drug: Sodium Hyaluronate Injection
intra-articular injection




Primary Outcome Measures :
  1. Visual Analogue Scale for knee pain [ Time Frame: six weeks of the initial injection ]
    The investigator and the subject both evaluate the pain intensity per VAS before injection. VAS ranges from o to 10, 0=no pain, 10=pain as bad as can be.


Secondary Outcome Measures :
  1. WOMAC for knee pain [ Time Frame: six weeks of the initial injection ]
    WOMAC includes 3 items: pain, stiff and physiological function. 0=no, 4=as bad as can be.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females at the age of 40-75 years old
  2. Conforming to the diagnosis standard of the American College of Rheumatology in 2009: knee pain and osteophyte determined with X-ray, and at least one of the following items:

    • above 50 years old
    • morning stiffness less than 30 minutes
    • knee joint with fricative when moving
  3. The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side was less than 40mm when walking on flat ground.
  4. The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence grading scale.
  5. Patients who have treatment requirements and can obey the therapeutic schedule
  6. Body mass index(BMI) ≤35kg/m2。
  7. Able to follow the clinical observation and follow up.
  8. The subjects are able to understand and sign the informed consent after fully understand this study, the disease, investigational drugs, the therapeutic schedule and the potential risks.

Exclusion Criteria:

  1. Positive signs of swelling or floating patella test,and there are obvious effusion of knee joint in clinical.
  2. Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
  3. Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor, villonodular synovitis, joint trauma, etc.
  4. Pregnant or lactating females.
  5. Participants who suffer from serious cardiovascular disease (Sudden cerebral infarction with sequela or myocardial infarction within recent 6 months), hepatic disease, kidney disease;Participants whose ALT and AST are twice or more than twice than that of the upper limit of normal value;Participants whose serum creatinine exceed the upper limit of normal value;Participants who suffer from dysfunction of blood coagulation (thrombocytopenia, bleeder disease, etc.)
  6. Participants who have systemic infection or infectious disease.
  7. Participants who suffer from serious skin defect or ulcer around the studying knee joint.
  8. Participants who suffer from typical varus or valgus deformities or lack of articular cavity.
  9. Participants with diabetes and have to inject insulin or who are not good enough to control the blood glucose (FBG ( fasting blood-glucose) ≥10mmol/L.)
  10. Participants who suffer from cancer (within 5 years) or Alzheimer's disease.
  11. Participants with score 0 or 4 of the studying knee joint evaluated by radiological Kellgren-Lawrence grading scale.
  12. Participants who have hormone drugs within 2 weeks or analgesic drugs within 1 week before this trial or take part in other clinical trials.
  13. Participants whose studying knee receives articular cavity therapy within 3 months, containing intra articular administration, articular irrigation and arthroscopic surgery
  14. Participants with an allergy to the experimental drugs.
  15. Participants who are not suitable for this trial judged by the researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323451


Contacts
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Contact: Changqing Zhang, PhD +86-13003104089 zhangcq@sjtu.edu.cn
Contact: Shengbao Chen, MD +86-18930172088 shengbaocheng@163.com

Locations
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China, Shanghai
Shanghai Sixth People's Hospital. Orthopedics. Recruiting
Shanghai, Shanghai, China, 200233
Contact: Changqing Zhang, PhD    +86-13003104089    zhangcq@sjtu.edu.cn   
Contact: Shengbao Chen, MD    +86-18930172088    shengbaocheng@163.com   
Sponsors and Collaborators
Shanghai Qisheng Biological Preparation Co., Ltd.
Investigators
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Principal Investigator: Changqing Zhang, PhD Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233.
Principal Investigator: Shigui Yan, PhD Hangzhou,Chian. The Second Affiliated Hospital of Zhejiang University School of Medicine. Orthopedics. Not yet recruiting. No.88 Jiefang Road Hangzhou.China Post Code:310009

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Responsible Party: Shanghai Qisheng Biological Preparation Co., Ltd.
ClinicalTrials.gov Identifier: NCT02323451     History of Changes
Other Study ID Numbers: QS20140506
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Chitosan
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants